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NCT03351478 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Sotagliflozin Versus Placebo and Empagliflozin in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking a DPP4 Inhibitor Alone or With Metformin
A Phase 3 study, sponsored by Lexicon Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 770
- Enrollment target
NCT03351478 is a Phase 3 study that has completed, run by Lexicon Pharmaceuticals. The registered enrollment target is 770 participants.
The verdict
NCT03351478, a Phase 3 study, has completed, sponsored by Lexicon Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 770 participants
- Enrollment target
Study Summary
The purpose of the study is to demonstrate the superiority of sotagliflozin versus placebo on hemoglobin A1c (HbA1c) reduction in participants with type 2 diabetes (T2D) who have inadequate glycemic control on a DPP4(i) with or without metformin.
Interventions
- DRUG Placebo
- DRUG Empagliflozin
- DRUG Sotagliflozin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 770 participants |
| Start Date | 2017-11-27 |
| Est. Completion | 2019-05-16 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03351478
The ClinicalTrials.gov registry entry for NCT03351478 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 770 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Lexicon Pharmaceuticals, which has 56 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03351478 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03351478 about?
NCT03351478 is a clinical study titled "Efficacy and Safety of Sotagliflozin Versus Placebo and Empagliflozin in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking a DPP4 Inhibitor Alone or With Metformin". The purpose of the study is to demonstrate the superiority of sotagliflozin versus placebo on hemoglobin A1c (HbA1c) reduction in participants with type 2 diabetes (T2D) who have inadequate glycemic control on a DPP4(i) with or without metformin.
What is the current status of trial NCT03351478?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 770 participants. The study started on 2017-11-27. Estimated completion is 2019-05-16.
What interventions are being tested in trial NCT03351478?
The interventions under investigation include: Placebo (DRUG), Empagliflozin (DRUG), Sotagliflozin (DRUG).
Who is sponsoring clinical trial NCT03351478?
This trial is sponsored by Lexicon Pharmaceuticals, which has 56 total clinical trials registered on ClinicalTrials.gov.
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